MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number	5F061503CS
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient was undergoing a stent placement procedure using a lifestent vascular stent.During the procedure, the stent allegedly failed to expand fully.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H11: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product, and the product was found to have met the specification prior to shipment.Investigation summary: the sample is not available for evaluation.Provided images demonstrate the placed stent, and an additional stent that has been placed overlapping with an overlapping section of approximately 15-20mm.Resolution of the images is poor, and a stent twisting cannot be identified.A device deficiency of the placed stent cannot be identified.The investigation leads to inconclusive result.A manufacturing related issue could not be found.The vessel was not tortuous but moderately calcified, the lesion was pre dilated, and 6fx45cm introducer with 0.014" guidewire were used for access.The vessel diameter was 6mm at the lesion site.During deployment, the system was correctly held at the stability sheath, and the user did not experience difficulty.The lesion/ stent was post dilated with a 5mm balloon.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g2, g3, h6 (patient, device, result, conclusion).Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent a stent placement procedure using a lifestent vascular stent in contralateral, right common femoral artery, the stent allegedly failed to expand fully.Further, the stent was allegedly twisted.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22381544
• Report Number: 9681442-2025-00203
• Device Sequence Number: 15848546
• Product Code: NIP
• UDI-Device Identifier: 00801741120206
• UDI-Public: (01)00801741120206(17)271105(10)ANJY0185
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5F061503CS
• Device Lot Number: ANJY0185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 63 KG